Adjunctive brexpiprazole benefits seen in Asian adults with MDD in real-world

Up to 3 months of treatment with adjunctive brexpiprazole helps with symptom severity in Asian adults with major depressive disorder (MDD) and inadequate response to antidepressants in a real-life clinical setting in Singapore.

Prospective observational data from patients with MDD who initiated brexpiprazole in addition to their existing antidepressant medications showed symptom improvements, as measured using the Patient Health Questionnaire-9 (PHQ-9) and Clinical Global Impression-Severity (CGI-S) scores—the coprimary endpoints.

From baseline to week 12, the mean PHQ-9 scores decreased by 4.8 (95 percent confidence interval [CI], −10.0 to 0.5) based on paired t test analysis (p=0.0800) and by 4.7 (95 percent CI, −8.1 to −1.3) based on linear mixed model (LMM) analysis (p=0.0075), translating to a one-grade improvement in depression severity (from moderately severe to moderate). [Clin Psychopharmacol Neurosci 2024;22:531-536]

Meanwhile, the mean CGI-S score decreased by 1.3 at week 12 based on paired t test (95 percent CI, −2.2 to −0.4; p=0.0050) and LMM (95 percent CI, −1.9 to −0.6; p=0.0002) analyses. This was equivalent to a reduction in severity from moderately ill to mildly ill.

Remission was achieved in 25 percent of patients according to PHQ-9 scores and in 38 percent of patients based on CGI-S scores.

Significant improvements in overall functioning and anxiety symptoms were also observed at week 12. The mean total Sheehan Disability Scale (SDS) score decreased by 8.5 from baseline (95 percent CI, −13.0 to −4.0; p<0.001), while the mean Generalized Anxiety Disorder 7-item scale (GAD-7) score dropped by 6.2 (95 percent CI, −9.9 to −2.6; p<0.01).

These findings show evidence that Asian patients with MDD treated with adjunctive brexpiprazole in real-world settings experience outcomes that match those of non-Asian patients treated in the more-controlled setting of the clinical trial, as the investigators pointed out. [J Clin Psychiatry 2015;76:1224-1240; J Clin Psychiatry 2018;79:17m12058; Curr Med Res Opin 2018;34:633-642]

In the present study, the response rates (31−38 percent) and remission rates (25−38 percent) mirror those reported in previous trials, they added. The same is true for the improvements in SDS and GAD-7 scores. [Brain Behav 2016;6:e00520]

The study included 20 patients, of whom 17 (mean age 34.9 years, 70.6 percent female, mean number of previous depressive episodes 1.9) were included in the intention-to-treat analysis; all were assessed for safety.

The rates of adverse events (AEs) and treatment-related AEs were 55 percent and 50 percent, respectively. AEs led to treatment discontinuation in two patients (10.0 percent), and a serious AE was documented in one patient (5.0 percent). Weight gain (25 percent) was the most common AE, with the mean weight increasing by 2.35 kg from baseline to week 12 (p=0.0003). None of the patients died or had severe AE.

“Treatment with brexpiprazole was well-tolerated for up to 3 months… The AE profile is largely consistent with earlier studies, [and] no new or unexpected study concerns were noted,” according to the investigators.

“[Collectively, the present data] support the results from earlier brexpiprazole trials and provide a real-world snapshot of the use of adjunctive brexpiprazole in Asian patients with MDD in Singapore… These findings are encouraging considering patients had inadequate response to ≥1 antidepressant before initiating brexpiprazole, and the study was conducted during the COVID-19 pandemic where patients’ mental health could have been negatively impacted,” they said.